A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer
A Phase IIb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell Inj.) or Topotecan in Patients With Relapsed Small Cell Lung Cancer
1 other identifier
interventional
164
1 country
14
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Belotecan administered 5 days every 3 weeks in comparison to Topotecan in Patients with relapsed small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2010
Longer than P75 for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 20, 2011
CompletedFirst Posted
Study publicly available on registry
December 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedDecember 27, 2018
December 1, 2018
7.3 years
April 20, 2011
December 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objectives Response Rate(ORR, %)
The response rate was defined as the test subject who had a complete response (CR) or a partial response (PR) as determined by the 'tumor response evaluation' criteria specified in the research protocol
Up to 18weeks
Secondary Outcomes (2)
Overall Survival(OS)
7years
Progression Free survival(PFS)
Up to 18weeks
Study Arms (2)
Belotecan
EXPERIMENTALCamtobell Injection
Topotecan
ACTIVE COMPARATORHycamtin Injection
Interventions
Eligibility Criteria
You may qualify if:
- At least 18 years of age
- Histological or cytological diagnosis of SCLC
- Limited disease (LD) or Extensive disease (ED) at time of study entry
- Recurrent or progressive SCLC ≥ 90 days of duration of response for firstline therapy
- Measurable disease defined by RECIST criteria
- ECOG Performance Status of 0, 1, or 2
- Life expectancy ≥ 3 months
- Adequate bone marrow, Renal, Hepatic reserve:
- absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/mm3 platelet count ≥ 100,000 cells/ mm3 hemoglobin ≥ 9 g/dL Total bilirubin ≤ 1.5 mm3 Alanine aminotransferase (ALT) and aspartate aminotransferase(AST) ≤ 2.0 X ULN Alkaline Phosphatase (ALP) ≤ 2.0 X ULN Serum creatinine ≤ 1.5mg/dL or calculated creatinine clearance \> 60mL/min
- \- Signed a written informed consent
You may not qualify if:
- Active infection
- Symptomatic brain lesion
- Any other type of cancer during the previous 5 years
- Severe concurrent diseases
- Prior anticancer therapy within 4 weeks before enroll
- Active pregnancy test and Pregnant or nursing women
- Participation in any investigational drug study within 28 days prior to study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Chungbuk University Hospital
Daegu, South Korea
Keimyung University Dongsan Center
Daegu, South Korea
National Cancer Center
Goyang, 410-769, South Korea
Asan Medical Center
Seoul, South Korea
CHA Bundang Medical Center
Seoul, South Korea
Chung-Ang University hospital
Seoul, South Korea
Kyung Hee University Medical Hospital
Seoul, South Korea
Seoul National University Boramae Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Seoul St. Marys Hospital
Seoul, South Korea
Seoul Veterans Hospital
Seoul, South Korea
Yonsei Cancer Center
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
St. Vincents Hospital
Suwon, South Korea
Related Publications (1)
Kang JH, Lee KH, Kim DW, Kim SW, Kim HR, Kim JH, Choi JH, An HJ, Kim JS, Jang JS, Kim BS, Kim HT. A randomised phase 2b study comparing the efficacy and safety of belotecan vs. topotecan as monotherapy for sensitive-relapsed small-cell lung cancer. Br J Cancer. 2021 Feb;124(4):713-720. doi: 10.1038/s41416-020-01055-5. Epub 2020 Nov 16.
PMID: 33191408DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heung Tae Kim, M.D., Ph.D
National Cancer Center
- PRINCIPAL INVESTIGATOR
Jin Hyoung Kang, M.D., Ph.D
The Catholic University of Korea Seoul St. Marys Hospital
- PRINCIPAL INVESTIGATOR
Jin Young Kim, M.D., Ph.D
Keimyung University Dongsan Medical Center
- PRINCIPAL INVESTIGATOR
Dong-Wan Kim, M.D., Ph.D
Seoul National University Hospital
- PRINCIPAL INVESTIGATOR
Sang-We Kim, M.D., Ph.D
Asan Medical Center
- PRINCIPAL INVESTIGATOR
Hye Ryeon Kim, M.D., Ph.D
Yonsei Cancer Center
- PRINCIPAL INVESTIGATOR
Jin Hyuk Choi, M.D., Ph.D
Ajou University School of Medicine
- PRINCIPAL INVESTIGATOR
Ki Hyeong Lee, M.D., Ph.D
Chungbuk National University Hospital
- PRINCIPAL INVESTIGATOR
Ho Jung An, M.D., Ph.D
St. Vincents Hospital
- PRINCIPAL INVESTIGATOR
Chi Hoon Maeng, M.D., Ph.D
Kyung Hee University Medical Hospital
- PRINCIPAL INVESTIGATOR
Jin-Soo Kim, M.D., Ph.D
SMG-SNU Boramae Medical Center
- PRINCIPAL INVESTIGATOR
Joung Soon Jang, M.D., Ph.D
Choung Ang University Hospital
- PRINCIPAL INVESTIGATOR
Bong Seog Kim, M.D., Ph.D
Seoul Veterans Hospital
- PRINCIPAL INVESTIGATOR
Joo-Hang Kim, .D., Ph.D
CHA Bundang Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2011
First Posted
December 23, 2011
Study Start
September 1, 2010
Primary Completion
December 1, 2017
Study Completion
March 1, 2018
Last Updated
December 27, 2018
Record last verified: 2018-12